Chiropractic Force Versus Touch

Healthy Clinical Trial

— FVT  

Official title:

Comparison of EEG Changes Over Time Following Application of Chiropractic Adjustive Force vs Non-force Simulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249530
• Other study ID #: I-0015
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2024
• Source: Life University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Life University Center for Chiropractic Research is conducting a research study to better understand the physiologic and brain-based differences between the touch and force components of the chiropractic adjustment. Eligible individuals will either receive a chiropractic adjustment with force or a non-force stimulation. Individuals in the force stimulation group will receive an active spinal adjustment with a handheld instrument called an Activator. Individuals in the non-force stimulation group will have one Activator placed on the spine and another Activator clicked away from the spine. This study is not randomized. The first participant will receive an active spinal adjustment, and the second participant will receive a non-force stimulation at the same locations as the first participant. This pattern repeats until all individuals have been recruited (n=30). Outcome assessments include resting state electroencephalography (EEG), electrocardiography (ECG), and blood pressure. Outcome assessments will be captured prior to the adjustment or non-force stimulation, after the adjustment or non-force stimulation, and one week later. Individuals will also undergo a standard health history and chiropractic physical exam at the start of participation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• You are between the age of 18 and 50.

• You have not had a chiropractic adjustment in the past 2 weeks.

• You are not currently receiving care such as acupuncture or physical therapy.

• You are currently not taking any medication that may change your brain patterns.

Exclusion Criteria:

• You do not have a history of recent spinal surgery or trauma.

• You do not have any other health conditions that may prevent you from receive chiropractic care. This could include diagnosed osteoporosis.

• You are not pregnant.

• You do not have a severe mental health condition.

• You do not have a known heart condition.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Chiropractic spinal adjustment
Chiropractic spinal adjustment
• Non-force simulation
Non-force simulation

Locations

Country	Name	City	State
United States	Life University Center for Chiropractic Research	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Life University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalography (EEG) Power spectrum	64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.	Baseline, beginning of the study
Primary	Electroencephalography (EEG) Power spectrum	64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.	through study completion, an average of 1 year
Primary	Electroencephalography (EEG) Power spectrum	64 channels of EEG will be recorded. A fast Fourier transform will be computed to provide a power spectrum of frequencies 1-50.	One week follow up
Primary	Electrocardiogram (ECG) R-R intervals	Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.	Baseline, beginning of the study
Primary	Electrocardiogram (ECG) R-R intervals	Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.	through study completion, an average of 1 year
Primary	Electrocardiogram (ECG) R-R intervals	Three leads will be placed on the torso to capture a Lead II ECG. R-R intervals will be calculated.	one-week follow up
Primary	Blood pressure	Blood pressure will be captured using an automatic blood pressure cuff	Baseline, beginning of the study
Primary	Blood pressure	Blood pressure will be captured using an automatic blood pressure cuff	through study completion, an average of 1 year
Primary	Blood pressure	Blood pressure will be captured using an automatic blood pressure cuff	one-week follow up